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FDA Approves Moderna’s RSV Vaccine for Seniors, the Company’s Second-Ever Product
The Food and Drug Administration on Friday approved Moderna’s vaccine for respiratory syncytial virus for adults ages 60 and above, the company’s second-ever product to enter the U.S. market. The decision is a win for Moderna, which desperately needs another revenue source amid plunging demand for its COVID jab, its only commercially available product.
The approval of Moderna’s shot is based on a late-stage trial on older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 seniors every year and results in 60,000 to 160,000 hospitalizations, according to data from the Centers for Disease Control and Prevention.
An advisory panel to the CDC will vote in June on recommendations for the use and intended population of Moderna’s shot. The company expects an equal recommendation to existing RSV shots from GSK and Pfizer, Moderna executives said during an earnings call on May 1.
A positive recommendation from the CDC would allow Moderna’s vaccine to compete against GSK and Pfizer, which launched their respective shots in the U.S. last fall. Pfizer’s vaccine has so far lagged behind GSK’s, but both shots have so far recorded hundreds of millions in sales.
The Addiction Crisis Is Even Worse Than Headlines Can Convey
Everyone knows the country’s addiction crisis is bad, but even the direst headlines just barely scratch the surface.
Why it matters: We spend a lot of time talking about drug overdose deaths, which each year are nearly double the number of Americans killed in the Vietnam War. But overdose deaths are only one measure of the drug epidemic’s severity — and even the formal toll doesn’t capture the true extent of drugs’ lethal power, experts say.
The big picture: The evolving opioid epidemic has morphed again into a multi-drug crisis centered on fentanyl, which is often paired — knowingly or unknowingly — with other illicit drugs.
When put together with the mental health crisis — which I wrote about in-depth last week — the behavioral health burden is enormous. And keep in mind, substance abuse and mental illness often feed off of one another.
Thousands of Cancer Patients to Trial Personalized Vaccines
Thousands of NHS cancer patients in England are expected to get access to trials of a new type of treatment using vaccines to fight their disease.
Thirty hospitals so far have signed up for the Cancer Vaccine Launch Pad. It is designed to match patients with forthcoming trials using mRNA technology, as found in current COVID jabs.
The vaccines are designed to prime the immune system to recognize and destroy any remaining cancer cells and reduce the risk of the disease recurring.
Moderna and BioNTech have begun or are planning trials of mRNA vaccines against a range of tumor types including lung, breast and bladder cancer.
Bavarian Nordic, CEPI Announce Plan to Advance Mpox Vaccine for African Children
Bavarian Nordic and the Coalition for Epidemic Preparedness Innovations (CEPI) yesterday announced a partnership to advance the development of Bavarian Nordic’s mpox vaccine for children in Africa.
CEPI has awarded $6.5 million to support phase 2 clinical trials of the MVA-BN nonreplicating vaccine in children ages 2 to 12 as compared to adults. The study will enroll 460 people in endemic regions who don’t have a history of mpox illness or vaccination. Participants will receive two doses of the vaccine.
The study is expected to launch this year in one or more African countries.
How to Look Up the Money Your Doctor Is Getting From Big Pharma
When doctors take money or gifts from pharmaceutical companies those are required by law to be reported to the U.S. government. But did you know there’s a website where you can look up how much money any doctor in the U.S. has taken from healthcare companies? It’s completely free and run by Medicare.
A new study from JAMA found that 26 of 28 physicians who had given endorsements to healthcare products on the social media platform X had taken at least one payment from the companies making those products, according to news outlet STAT on Thursday. However, roughly half of the physicians had published no research related to the topics they were endorsing.
The website is called Open Payments and is run by the Centers For Medicare and Medicaid Services. And you can type in the name of any doctor in the country to see their latest data. For example, you can plug in any celebrity doctor and see which companies might be giving them money.
Pfizer Sees Lung Cancer Drug Topping $1 Billion in Sales Following Impressive 5-Year Data
Pfizer (PFE.N) said it expects its cancer drug Lorbrena to top $1 billion in annual sales by 2030 on the strength of data presented on Friday showing most patients treated for a rare form of advanced lung cancer in a clinical trial were alive without the disease worsening after five years.
Lorbrena, like Pfizer’s Xalkori, is designed to treat cancer with a mutation of a specific gene called anaplastic lymphoma kinase, or ALK. “We believe this is a blockbuster opportunity for Pfizer,” Chief Oncology Officer Chris Boshoff said in an interview.
Lorbrena, which won U.S. approval in March of 2021, had sales of $164 million in the first quarter of 2024, up 46% from a year earlier. The company expects double-digit growth to continue in coming quarters, Boshoff said.
Investors have fled from Pfizer as billions of dollars in COVID-19 vaccine and treatment sales disappeared with waning pandemic concerns.
Parental Vaccine Hesitancy Shifted With COVID Vaccines
Centers for Disease Control and Prevention (CDC) investigators report that about one in five U.S. children had parents reporting vaccine hesitancy (VH) from 2019 to 2022, and VH increased after the authorization of the COVID-19 vaccine for children aged 5 to 11 years and declined for children aged 6 months to 4 years.
The findings are published in Vaccine and come as the CDC’s VRBPAC (Vaccines and Related Biological Products Advisory Committee) prepares to meet next week to pick COVID and influenza strains to include in updated vaccines.
EU Watchdog Green Lights First Vaccine Against Chikungunya
Europe’s medicines watchdog Friday gave the thumbs up for the continent’s first vaccine against the mosquito-born Chikungunya virus, warning climate change could boost the spread of the disease.
Chikungunya, also called CHIK fever, is an illness similar to Dengue or Zika and causes high fever and severe joint pain which is often debilitating and varies in duration.
The EMA has granted marketing authorization, which is the last step before the vaccine is granted permission for use by the European Commission.
Made by Valneva Austria, the Ixchiq vaccine is a single-dose powder or injection that triggers the production of neutralizing antibodies 28 days after being given to people over 18.
